ANATOMICAL AND BIOLOGICAL PRESERVATIVE AND IMPROVED EMBALMING COMPOSITION AND METHOD

Abstract: An improved preservative and embalming composition and method has been developed. The embalming fluid is a mixture including glutaraldehyde, an aromatic ether of ethanol, e.g. phenoxyethanol, at least one alcohol, and a polyhydric alcohol humectant. The formulation has no formaldehyde.

Description: Anatomical and Biological Preservative and Improved Embalming Composition and Method FIELD OF THE INVENTION The invention relates to an anatomical and biological preservative and improved embalming compositions that are free of formaldehyde. BACKGROUND OF THE INVENTION Anatomical and biological preservatives and embalming fluids typically used contain significant quantities of formaldehyde. The formaldehyde solutions used for preser- vation fix the tissues of the specimen and preserve the specimen from decay. Many plant and animal species are preserved for academic study. Smaller life forms are immersed in a preservative. Larger vascular animals are injected in the circulatory system and elsewhere with a preservative. Although formaldehyde solutions have histor¬ ically been the preservative fluid of choice, there are a number of drawbacks. Formaldehyde is associated with certain health and environmental risks. Also, formaldehyde can cause problems with the specimen, because it dehydrates the tissue. Alternative preservation fluids have been proposed including phenols, alcohols, and certain acid preparations. Other methods have included initially fixing the specimen in formaldehyde, rinsing the specimen and placing the specimen in another solution that does not include formal¬ dehyde. Human remains used for morbid anatomy study are included in the specimens needing preservation. The desire to eliminate exposure to formaldehyde has been examined by investigators involved in cadaver preservation. ineski et al., "Phenoxyethanol as a Nontoxic Preservative in the Dissection Laboratory," Acta Anat. Vol. 136 pp. 155-158 (1989) . The cadavers were embalmed by injection with about 24 liters of formaldehyde fluids. After embalming the cadavers were immersed or completely wrapped with cloth heavily soaked in phenoxyethanol. Exposure of workers to phenoxyethanol is preferable environmentally to formalde¬ hyde. However, the success of the technique depended on good initial preparation of the cadavers with a formalde¬ hyde fluid. Other alternatives to formaldehyde include a formula¬ tion made with a 1,4-dioxane ring compound, U.S. Patent No. 3,264,182; a process of pre-fixation with formaldehyde followed by preservation in glycols, U.S. Patent No. 3,573,082; and solutions of starch glycerite for marine animals to preserve color, U.S. Patent No. 4,121,944. The formaldehyde embalming solutions are injected into the arteries and also introduced into the body cavity. Generally the cavity formulation is more concentrated because the naturally occurring fluids in the body cavity will dilute the formaldehyde formulation. The formaldehyde solutions also typically contain other additives such as humectants. Although formaldehyde solutions have histori¬ cally been the embalming fluids of choice, there are a number of drawbacks as discussed above for biological preservatives. Formaldehyde can cause problems with the presentation of the body, because it dehydrates the tissue. In U.S. Patent No. 3,057,775 issued October 9, 1962 to Randow entitled "Embalming Composition", glutaraldehyde was used instead of formaldehyde as a preservative in the embalming fluid. Glutaraldehyde was mixed with other preservatives in the formulations disclosed. If glutaral¬ dehyde were used as the sole preservative, it would not be less than 7% of the solution. However, glutaraldehyde should be stabilized in the fluid to prevent oxidation and may polymerize in certain concentrations. Glutaraldehyde is tolerable to handle and does not have a noxious odor. Also, glutaraldehyde does not dehydrate tissue. U.S. Patent No. 3,912,809 issued on October 14, 1975 to Randow entitled "Disinfecting Embalming Composition", discloses a fluid that is 2% by weight glutaraldehyde and an alkalizing agent to adjust the pH of the solution to pH 8 ~ 8.5. The glutaraldehyde is not stable in the alkaliz¬ ing solution for more than a few weeks and the disclosure recognizes the problem of polymerization when glutaral¬ dehyde is present in large concentrations. According to the patent, the shelf life problem is resolved by initially preparing two solutions. One is the glutaraldehyde solu¬ tion which typically also includes formaldehyde and the other is the alkalizing solution. The two solutions are mixed as needed. This composition is reported to signifi- cantly reduce the microbial growth in human remains. A need exists for a preservative and embalming fluid that is safe to handle and is relatively simple to prepare for use. Previous alternatives to formaldehyde fluids have been solutions with stability problems associated with higher levels of glutaraldehyde or were cumbersome to use. SUMMARY OF THE INVENTION A new anatomical and preservative fluid and embalming composition has been developed. The preservative is capable for use for specimens that are immersed or injected with the fluid into the vascular system. The fluid is a mixture of glutaraldehyde, at least one aromatic ether of ethanol preferably phenoxyethanol, at least one alcohol, and a humectant. The composition may be prepared initially as a concentrate or diluted with water to the desired concentration. The fluid may contain various additives conventionally used in preservatives, including a color additive, pH buffer, an antioxidant, odorant and mixtures thereof. A biocide may also be added for additional cidal activity in addition to the fluid components to kill mold and other microbes when the specimen is going to be used for a prolonged time. The fluid exhibits excellent cidal activity for microbes such as viruses. DETAILED DESCRIPTION OF THE INVENTION The improved preservation and embalming fluid of the present invention is a unique mixture of glutaraldehyde, at least one aromatic ether of ethanol, at least one humec- tant, and at least one alcohol. Generally, the fluid is diluted with water prior to use. The fluid can be prepared in dilutions appropriate for whole specimen preservative and vascular injection for biological studies. The fluid can be used for embalming including arterial injection and cavity fluid. The preferred formulation includes the following components by volume after dilution: glutaraldehyde from about 0.5% to about 3.5%, aromatic ether of ethanol prefer¬ ably phenoxyethanol from about 1% to about 3%, humectant from about 1% to about 9%, and an alcohol from about 27% to about 37%; and made up with water to the desired concentra¬ tion. A preferred humectant is a polyhydric alcohol or mixtures of more than one polyhydric alcohol. The pre¬ ferred polyhydric alcohols are glycerol and 1,2 propane- diol. Another polyhydric alcohol humectant is hexylene glycol. A preferred aromatic ether of ethanol is phenoxy¬ ethanol. The preferred components are not intended to limit the scope of the inventions and alternative compo¬ nents within the scope of the invention will be recognized by those skilled in the art. The following Example 1 is an illustration of the improved composition that can be used for specimen preser¬ vation. EXAMPLE 1 Components Percent by Volume Ethyl Alcohol 33% Glutaraldehyde 3% 1-2 Propanediol 0.7% Phenoxyethanol 2% Glycerol 3% The rest of the volume is made up with water. In addition, ethoxyethanol in the range of 0.5% to 0.9% by volume may be added to Example 1. Dimethyl sulfoxide may also be used preferably in the range of 0.5% to 1.0%. Ethanol is a preferred alcohol. Small amounts of isopropanol, methanol or mixtures thereof can be used as a denaturant or other¬ wise in the formulation. In addition to the components in Example 1, a pH buffer preferably sodium phosphate and/or anti-oxidant may be included to maintain the stability of the glutaralde¬ hyde. The pH buffer would adjust the pH in the range of pH~7 to pH~9 with the preferred range of pH 8.0 - 8.1. Also, a biocide may be added to further deter microbial growth. In addition, other additives conventionally used in preservation fluids such as color additives may be included. Color additives are used in vascular systems of biological specimens for identification. It is not intend¬ ed to limit the claimed formulation to exclude additives known to be used in preservation compositions that would be compatible with the formulation of the present invention. The improved composition includes glutaraldehyde in relatively small concentrations. Anatomical tissues treated with this fluid have exhibited good color retention in muscle tissue of cadavers. The specimens have no odor and are easy to work with. The more glutaraldehyde is used in the formulation the more rigid the joints will be of specimens with a skeletal structure. The following Examples 2 and 3 are illustrations of the improved embalming composition for use in arterial injection. The volume in addition to the components is made up with water in both examples. EXAMPLE 2 Components Percent by Volume Ethyl Alcohol 28.5% Glutaraldehyde 0.5% 1-2 Propanediol 1.24% Phenoxyethanol 1.47% Glycerol 5% The fluid in Example 2 has been used in human remains. The composition preserved the body for at least seven to ten days. EXAMPLE 3 Components Percent by Volume Ethyl Alcohol 29.5% Isopropanol 1.5% Glycerol 1.3% Glutaraldehyde 3.2% Phenoxyethanol 2.2% Ethoxyethano1 0.8% Propanediol 0.6% Sodium Phosphate buffer added to adjust to pH 8.0-8.1 In addition to the components in Example 2, a pH buffer and/or anti-oxidant may be included to maintain the stability of the glutaraldehyde. The pH buffer would adjust the pH in the range of pH-7 to pH~9. Also, a biocide may be added to further deter microbial growth. For instance, a bactericide or a viricide may be included such as benzalkonium chloride or other quaternary ammonium compounds. In addition, other additives conventionally used in embalming fluids such as color additives or an odorant such as perfume may be included. In Example 3 the isopropanol is added as one of the alcohols and also serves as a denaturant. Methanol can also be used in small quantities as a denaturant. After 9 days at room temperature bodies prepared with Example 3 exhibited no visible signs of dehydration. After 9 days a body prepared with Example 3 was put in a cooler and autopsied two weeks from the date of embalming. The tissue was preserved exceptionally well with the muscle maintain¬ ing the same color. The body did not have an odor. It is not intended to limit the claimed formulation to exclude additives known to be used in embalming composi¬ tions that would be compatible with the formulation of the present invention. The formulation of this invention may be used as a cavity fluid for embalming internal organs. One cavity formulation is prepared according to Example 4. EXAMPLE 4 Components Percent by Volume Ethyl Alcohol 35.63% Glutaraldehyde 1.13% Phenoxyethanol 2.45% Glycerol 5% Ethoxyethano1 0.9% 1-2 Propanediol 2.48% The fluid may also include dimethyl sulfoxide (DMSO) in about 0.5% to about 1% by volume of the fluid. The DMSO may be a more preferred additive to a cavity fluid. The formulation in Example 5 below is another composi¬ tion for a cavity fluid. EXAMPLE 5 Components Percent by Volume Ethyl Alcohol 31.4% Isopropanol 1.7% Glycerol 2.5% Phenoxyethano1 1.2% Glutaraldehyde 3.0% Propanediol 1.2% Ethoxyethanol 0.7% Sodium Phosphate buffer added to adjust to pH 8.0-8.1 The formulation in Example 6 below is another alterna¬ tive composition for a cavity fluid. EXAMPLE 6 Components Percent by Volume Ethyl Alcohol 31.4% Isopropanol 1.7% Glycerol 2.5% Phenoxyethano1 1.2% Glutaraldehyde 3.5% Propanediol 1.2% Ethoxyethanol 0.7% Sodium Phosphate buffer added to adjust to pH 8.0-8.1 The embalming method of the present invention utilizes the new fluid described above. Typically, the fluid is injected by arterial delivery into the subject and allowed to penetrate the tissue. The fluid and method of this invention exhibits excellent penetration and delivery characteristics as compared to formaldehyde based fluids. Also, discolorations caused by hematomas and other condi¬ tions were lessened when the deceased was embalmed using the improved fluid of the present invention. The improved fluid also relieves blood clots which can impair the preservation of the body. This is particularly important if the embalming process is delayed after death and blood clots form prior to injection of the fluid. The fluid of the present invention appears to break up the blood clots and improve delivery of the fluid through the arteries. The formaldehyde fluids do not exhibit alleviation of discoloration or break up blood clots as compared to the fluid and method of the improved embalming composition described herein. Generally, the arterial fluid is made up of a less concentrated solution within the prescribed ranges. The cavity fluid is introduced into the central body cavity of the deceased, and this fluid is generally more concentrated within the ranges. The glutaraldehyde component in the present fluid is a relatively small concentration at levels not susceptible to polymerization. Also, the improved fluid is stable and does not require multiple mixing steps with more than one solution. The same solution may be diluted as desired for use as an arterial or cavity fluid. The examples and methods described herein are not intended to limit the scope of the invention. Those skilled in the art will recognize variations and substitu- tions in the composition and method that fall within the scope of the invention.

Claims: CLAIMS 1. A preservative and embalming fluid comprising glutaraldehyde; at least one aromatic ether of ethanol; at least one alcohol; and at least one humectant. 2. A preservative and embalming fluid of claim 1 wherein said aromatic ether of ethanol is phenoxyethanol. 3. A preservative and embalming fluid of claim 1 wherein said alcohol is ethanol. 4. A preservative and embalming fluid of claim 1 wherein said humectant is selected from the group consist- ing of a polyhydric alcohol or mixtures thereof. 5. A preservative and embalming fluid of claim 1 wherein said glutaraldehyde is from about 0.5 to about 3.5% by volume of the fluid. 6. A preservative and embalming fluid of claim 1 wherein said aromatic ether of ethanol is from about 0.5% to about 0.9% by volume of the fluid. 7. A preservative and embalming fluid of claim 1 wherein said alcohol is from about 27% to about 37% by volume of the fluid. 8. A preservative and embalming fluid of claim 1 wherein humectant is from about 1% to about 9% by volume of the fluid. 9. A preservative and embalming fluid of claim 1 additionally comprising a color additive. 10. A preservative and embalming fluid of claim 1 additionally comprising a pH buffer. 11. A preservative and embalming fluid of claim 1 additionally comprising an antioxidant. 12. A preservative and embalming fluid of claim 1 additionally comprising a biocide. 13. A preservative and embalming fluid of claim 1 additionally comprising a perfume additive. 14. A preservative and embalming fluid of claim 3 additionally comprising one of the group consisting of isopropanol, methanol and mixtures thereof. 15. A preservative and embalming fluid of claim 4 wherein said polyhydric alcohol is selected from the group consisting essentially of glycerol, 1-2 propanediol, hexylene glycol and mixtures thereof. 16. A method of embalming comprising: preparing a fluid according to claim 1; diluting the fluid with water to obtain fluid volumes for the components in the range of claims 5, 6, 7 and 8; and introducing the fluid into a body. 17. A method of claim 16 wherein said introduction is arterial injection. 18. A method of claim 16 wherein said introduction is into the body cavity. 19. A method of preserving a biological specimen comprising: preparing a fluid according to claim 1; diluting the fluid with water to obtain fluid volumes for the components in the range of claims 5, 6, 7 and 8; and introducing a specimen into the fluid. 20. A method of preserving a biological specimen comprising: preparing a fluid according to claim 1; diluting the fluid with water to obtain fluid volumes for the components in the range of claims 5, 6, 7 and 8; and introducing the fluid into the vascular system of the specimen.

Inventors: CAMPBELL JAMES W, MARGRAVE JOHN L, CAMPBELL, JAMES, W., MARGRAVE, JOHN, L.
Applicants: EFH INC, EFH, INC.
Application year: 1994
Main classification: A01N1
IPC codes: A01N1